Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan
Department of Rheumatology, University of Yamanashi, Chuo, Japan.
Ann Rheum Dis. 2024 Jan 2;83(1):96-102. doi: 10.1136/ard-2023-224343.
The LoVAS trial reported non-inferiority in remission induction rates between the reduced-dose and conventional high-dose glucocorticoid regimens plus rituximab for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 6 months; however, maintenance glucocorticoid requirements and long-term outcomes are unknown.
A total of 140 patients with new-onset ANCA-associated vasculitis without severe glomerulonephritis or alveolar haemorrhage were randomised to receive reduced-dose prednisolone (0.5 mg/kg/day) plus rituximab (375 mg/m/week×4) or high-dose prednisolone (1 mg/kg/day) plus rituximab. After achieving remission, patients received the rituximab maintenance therapy (1 g/6 months).
A total of 134 patients were analysed. Among patients who achieved remission with the protocolised treatments, the majority of patients in the reduced-dose group (89.7%) and 15.5% in the high-dose group discontinued prednisolone (median time to withdrawal, 150 and 375 days, respectively). During 24-month trial period, two patients in the reduced-dose group (2.8%) died, while five patients in the high-dose group (7.6%) died (p=0.225). Relapse occurred in nine patients in the reduced-dose group (13.0%) (two major and seven minor) and five in the high-dose group (7.6%) (two major and three minor) (p=0.311). Serious adverse events (SAEs) were less frequent in the reduced-dose group (36 events in 19 patients, 27.5%) than in the high-dose group (54 events in 30 patients, 46.2%) (p=0.025).
At 24 months, frequencies of relapse did not differ between the groups, and SAEs were less frequent in the reduced-dose group due to the lower event rate in the 6-month induction phase. The bias to myeloperoxidase-ANCA positivity (85.8%) in the trial population should be noted.
NCT02198248.
LoVAS 试验报道，在 6 个月时，对于抗中性粒细胞胞浆抗体（ANCA）相关性血管炎，与常规高剂量糖皮质激素加利妥昔单抗相比，低剂量糖皮质激素加利妥昔单抗方案在缓解诱导率方面非劣效；然而，维持糖皮质激素的需求和长期结果尚不清楚。
共有 140 例无严重肾小球肾炎或肺泡出血的新发 ANCA 相关性血管炎患者随机接受低剂量泼尼松龙（0.5mg/kg/天）加利妥昔单抗（375mg/m/周×4 次）或高剂量泼尼松龙（1mg/kg/天）加利妥昔单抗。达到缓解后，患者接受利妥昔单抗维持治疗（1g/6 个月）。
共分析了 134 例患者。在接受方案治疗达到缓解的患者中，低剂量组（89.7%）和高剂量组（15.5%）的大多数患者停用了泼尼松龙（中位停药时间分别为 150 天和 375 天）。在 24 个月的试验期间，低剂量组有 2 例（2.8%）患者死亡，而高剂量组有 5 例（7.6%）患者死亡（p=0.225）。低剂量组有 9 例（13.0%）（2 例主要，7 例次要）和高剂量组有 5 例（7.6%）（2 例主要，3 例次要）（p=0.311）患者复发。低剂量组（19 例患者中有 36 例事件，27.5%）发生严重不良事件（SAE）的频率低于高剂量组（30 例患者中有 54 例事件，46.2%）（p=0.025）。
在 24 个月时，两组的复发频率没有差异，由于 6 个月诱导期的事件发生率较低，低剂量组的 SAE 频率较低。应注意该试验人群对髓过氧化物酶-ANCA 阳性的偏倚（85.8%）。
NCT02198248。
